Healthcare technology developer Respiri (ASX: RSH) has revealed that the company has received the highly coveted CE Mark and TGA approval to list its Wheezo product on the Australian Therapeutics Goods Register (ARTG).
Respiri is marketing Wheezo as “the world’s first digital wheeze monitoring solution” which includes a sensor, a smartphone application and a state-of-the-art platform to help respiratory disease patients mitigate the effects of asthma.
Asthma is a chronic inflammatory disease that affects a person’s airways, causing recurring episodes of wheezing, breathlessness, chest tightness and coughing, particularly at night or in the early morning.
The condition affects millions of people worldwide with existing monitoring solutions falling short of patient expectations.
As part of the regulatory application process to obtain the CE Mark and TGA approval, Respiri also undertook a second audit of its quality management system to achieve an ISO 13485 certification – another regulatory hurdle medical device manufacturers must clear before their products are allowed to be marketed to the public.
The slew of approvals means that Respiri’s Wheezo product is proven to perform safely and achieve the stated performance claims for its intended use.
Overall, Respiri believes it is on track to commercialise Wheezo by Q4 2020 assuming various milestones are achieved over the coming year.
Clinical study agreement
The successful navigation of the review process means Wheezo was reclassified and is now cleared to be sold in 28 EU countries along with immediate approval for listing in the ARTG.
To further boost its clinical efficacy, Respiri also confirmed that it has struck a clinical study agreement with Swinburne University in Melbourne to examine how wheezing and asthma symptoms can be effectively measured as well as to determine small airway function.
The commissioned study is required for Respiri to correlate wheeze rates against current asthma measures such as the Forced Oscillation Technique (FOT) and Multiple Breath Washout (MBW) – two existing methodologies that attempt to quantify asthma and its effect on patients.
The study is expected to provide further evidence that Wheezo is an accurate ambulatory monitoring tool for asthma.
According to Respiri, the clinical trial at Swinburne will be completed by the end of April next year and is yet another regulatory signpost required before Respiri can commercialise Wheezo in Australia.
Today’s news comes as a welcome operational boost following several managerial changes at the company in recent weeks with Ross Blair-Holt resigning as director and replaced as chairman of the board last month by Nicholas Smedley.
Respiri also appointed a new chief executive officer at the end of November with Marjan Mikel taking the reins from Alastair Beard who was serving as interim chief executive officer after previous incumbent Mario Gattino surprisingly left in October with no explanation.
According to Respiri, its board reshuffle was carried out as part of the company’s focus on commercialising its technology including Wheezo.
Mr Mikel said that completion of the Swinburne study will allow Respiri to approach potential big pharma partners and make it more likely for physicians to recommend Wheezo to their patients.
In a bid to commercialise the product as quickly and effectively as possible, Respiri said it has already lined up a Malaysian manufacturing partner to scale up production and make Wheezo available next year, according to Mr Mikel.
“Respiri is pleased to announce that it has identified a suitably credentialed manufacturing partner operating out of Malaysia for Wheezo production. We are confident of finalising an agreement with our partners in Malaysia in the New Year,” said Mr Mikel.
According to the European Commission, there are more than 40 million asthma sufferers across Europe while Australia has around 3 million.
Those affected by the condition struggle with regular monitoring and depending on the severity, can be adversely affected for their entire lives.
Respiri claims that its Wheezo product can provide an effective “ambulatory tool” to help better manage their condition on a daily basis, and therefore, improve the quality of life for sufferers.
“The CE Mark and TGA clearance is a major accomplishment for Respiri as the submission required rigorous regulatory review against high clinical and safety standards,” said Nicholas Smedley, chairman of Respiri.
Mr Smedley added that “with this regulatory step completed, we are now at the point of commercialisation, with focus on our go-to-market strategy to make this innovative monitoring solution available to people with asthma as soon as possible.”
Respiri confirmed that it plans to have the first batch of 500 devices completed next month, to be gradually rolled out to clinicians and patients.
This morning’s news helped Respiri shares to add over 6% to trade at $0.085.